Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults
TL Holland, HF Chambers, HW Boucher… - Clinical Infectious …, 2019 - academic.oup.com
TL Holland, HF Chambers, HW Boucher, GR Corey, R Coleman, B Castaneda-Ruiz…
Clinical Infectious Diseases, 2019•academic.oup.comClinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped
into 2 categories: registrational trials intended to support regulatory approval of antibiotics
for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment
options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but
have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB
trial design considerations for investigators, sponsors, and regulators.
into 2 categories: registrational trials intended to support regulatory approval of antibiotics
for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment
options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but
have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB
trial design considerations for investigators, sponsors, and regulators.
Abstract
Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped into 2 categories: registrational trials intended to support regulatory approval of antibiotics for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB trial design considerations for investigators, sponsors, and regulators.
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